Phase 3
N=91
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
Thoracic Diseases · Postoperative Pain · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT03508830 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Average Daily In-Hospital Use of Opioids — 40; 45 Oral Morphine Equivalent per Day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal bupivacaine (Drug); Bupivacaine Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily In-Hospital Use of Opioids |
40; 45 | — |
| SECONDARY Average Daily In-Hospital Pain Score |
2.7; 3.1 | — |
| SECONDARY Number of Participants With Postoperative Pneumonia |
0; 1 | — |
| SECONDARY Length of Stay |
2.2; 2.3 | — |
Summary
The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.
Eligibility Criteria
Inclusion Criteria
- Robotic or Video-Assisted Lung Resection for All Indications
Exclusion Criteria
- Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
- Extra-Thoracic Procedures
- Hypersensitivity to Amide Local Analgesia
- Cardiac Conduction Abnormalities
- Hepatic Dysfunction
- Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage
Data sourced from ClinicalTrials.gov (NCT03508830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.